To registor medical device to US, we need to start with establishment registration. Let's see all about FDA fee to register your device.
Introduction
To get FDA's medical device registration process involves understanding and budgeting for various fees.
These fees are essential to comply with the U.S. Food and Drug Administration (FDA) regulations and ensure that your medical device can legally enter the U.S. market.
Knowing what fees apply and when they are due can help you plan effectively and avoid delays in your regulatory journey.
In this guide, we’ll break down the types of FDA fees related to medical device registration, when to pay them, and tips to streamline the process.
Who to pay FDA Fee? How much? When to pay?
1. Establishment Registration Fee
- Both Domestic and Foreign manufactures, reprocessors, specification developers, and relabelers of medical devices.
- How much? For 2024, the fee was $6,493 but now For 2025, the fee is $9,280. Too expensive.....
- When to pay? Payment is due during the annual registration renuwal period, typically between Oct 1st and Dec. 31th
2. Premarket Submission Fee
These fees apply to medical devices that require FDA approval or clearance before entering the market. The type of premarket submission depends on the device classification:
2.1 510k Premarket Notification Fee
- Who? Manufatuers of most Class II devices requring pre-market cleanrance (but some devices are 510k Exempt)
- Amount? Standard Fee: $21,659 (2024 Rate) $24,335 (2025 Rate)
Small business: $5,419 (2024 Rate) $ 6,084 (2025 Rate)
- When? Time of the submission
2.2 Premarket Approvla (PMA) Fee
- Who? Manufacturers of Class III devices requiring review and approval.
- Amount? Standard Fee: $441,547 (2024 Rate) $540,783 (2025 Rate)
Small business: $110,387 (2024 Rate) $135,196 (2025 Rate)
- When? Time of the submission
2.3 De Novo Classification Request Fee
- Who? Manufacturers seeking classification for novel devices without a predicate device
- Amount? Standard Fee: $132,588 (2024 Rate) $162,235 (2025 Rate)
Small business: $33,147 (2024 Rate) $40,559 (2025 Rate)
- When? Time of the submission
2.4 Humanitarian Device Exemption (HDE) Fee
- Who? Manufacturers of devices for rare conditions affecting fewer than 8,000 individuals annually.
- Amount? Fee exempt
3. Annual Program Fees for Accredited Third-Party Review Organizations
If a third-party organization reviews your 510(k) submission, it may charge additional fees. These fees are separate from FDA charges.
4. Small Business Fee Reduction
The FDA offers reduced fees for small businesses, defined as entities with gross revenues of $100 million or less.
To qualify:
Submit a Small Business Qualification Certification (Form FDA 3602).
Submit documentation supporting your revenue claims.
5. Other Fees
Depending on your device and its market lifecycle, you may also encounter fees for:
When to Pay FDA Fees for Medical Device Registration, In Summary:
1. Establishment Registration Fees
Paid annually during the registration renewal window (October 1st to December 31st).
Covers the following calendar year.
2. Premarket Submission Fees
Paid before or at the time of submission.
Your application will not be processed until the payment is confirmed.
3. Small Business Reduction
Submit your small business qualification form early, as approval can take several weeks.
Reduced fees apply only after qualification is granted.
4. Late Payment Penalties
Failure to pay fees on time can result in